JCXH-213 for relapsed or refractory CD19-positive B‑cell non-Hodgkin lymphoma
Open-label, Single-arm，Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
This study will try an in‑body mRNA‑LNP CAR therapy called JCXH-213 in adults with relapsed or refractory CD19-positive B‑cell non‑Hodgkin lymphoma to see if it is safe and can shrink tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing GoBroad Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06618313 on ClinicalTrials.gov |
What this trial studies
This interventional clinical trial gives JCXH-213, an mRNA‑LNP in vivo CAR therapy, to adults with relapsed or refractory CD19-positive B‑cell non‑Hodgkin lymphoma. Eligible patients have pathologically confirmed CD19-positive disease, measurable lesions per Lugano 2014, and ECOG performance status 0–1. Treatment is administered during a defined observation period, and patients may continue receiving the therapy afterwards if there are no major safety concerns and the investigator judges ongoing benefit. The study focuses on safety and tolerability as well as preliminary signals of anti-tumor activity measured by response criteria.
Who should consider this trial
Good fit: Adults with relapsed or refractory CD19-positive B‑cell non‑Hodgkin lymphoma who have measurable disease and good performance status (ECOG 0–1) are the intended candidates.
Not a fit: Patients with CD19-negative disease, poor performance status (ECOG >1), recent other malignancies within five years, or other conditions that increase risk from an in‑body CAR approach are unlikely to benefit.
Why it matters
Potential benefit: If successful, JCXH-213 could provide a faster, in‑body CAR therapy option that may induce tumor responses in people whose B‑cell lymphoma has returned or not responded to prior treatments.
How similar studies have performed: Similar in‑body mRNA‑LNP CAR approaches are largely novel, with promising preclinical data and only limited early‑phase human experience reported so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cytologically or histopathologically confirmed CD19-positive B-cell Hodgkin lymphoma according to WHO 2022 criteria, including but not limited to pathologically confirmed (1) diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); (2) follicular lymphoma (FL); (3)histologically transformed into diffuse large B-cell lymphoma; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) High-grade B-cell lymphoma (HGBCL) etc. * ECOG performance status 0 to 1. * Existing measurable lesions (Lugano 2014 criteria, as detailed in Appendix 2), meeting one of the following conditions: 1) nodal lesions with a long axis length exceeding 15 mm (short axis length is measurable); 2) extra-nodal lesions with both long axis and short axis lengths exceeding 10 mm. Exclusion Criteria: * Patients with other malignant tumors within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local radical prostatectomy, radical ductal carcinoma in situ, and radical thyroidectomy. * B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement. * Life expectancy less than 3 months.
Where this trial is running
Beijing
- Department of Lymphoma and Myeloma, Yuhengnan Road, Changping District, Beijing — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Kai Hu, Chief Physician — Beijing GoBroad Hospital
- Study coordinator: Kai Hu
- Email: HK13610956245@163.com
- Phone: +86 15810245863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.